Coming soon: the MDR podcast!

The new regulation on medical devices, which enters into force on May 26, affects not only pure medtech companies, but a wide range of companies in pharmaceuticals, biotechnology and cosmetics with requirements concerning, for example, combination products and products intended for aesthetic and non-medical purposes. Do you know what applies to your company? What is MDSW and what is PMCF? This and much more will be answered when SwedenBIO, in collaboration with Kickfile and Devicia, launches the MDR podcast soon, a podcast series dedicated to making this regulatory framework digestible for the industry's companies. Sofia Nordgren, CEO of Kickfile, is the host and your friend on the airwaves.

Why is this podcast needed, Sofia?

– Every day I meet companies, both Swedish and international, who have difficulty navigating all the requirements for medical devices, not least with the new medical device regulation. In the podcast, I hope, together with invited guests, to clarify some issues and give examples of how to navigate the new regulatory framework.

Who should listen to the podcast?

– Anyone working with or at the interface of medical devices. With short but content-rich sections, the idea is that everyone, regardless of previous experience and knowledge in the field, should be able to take away something of value.

What is your background in MDR?

– I have worked in medical technology all my professional life, both in manufacturing companies and for the last six years as a consultant. Since the MDR was published in 2017, I have been helping our customers almost daily to interpret how the requirements of the MDR affect their products and companies. Since 2014, I have also had the opportunity to work with standardization in medical technology, both as a member of Swedish technical committees but also in international working groups.

In connection with the new regulation coming into force, we have – together with Kickfile and Devicia, among others – also been involved in producing a white paper on the impact of MDR on medical device software. You can find it here.